The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain

This study has been completed.
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00924677
First received: June 18, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

Chronic osteoarthritis (OA) pain of the knee is not effectively abrogated by the available non-pharmacologic or pharmacologic treatments. Radiofrequency (RF) neurotomy is a therapeutic alternative for chronic pain. Here, the researchers investigate the efficacy of RF neurotomy applied to articular branches (genicular nerves) in treating knee joint pain.


Condition Intervention
Osteoarthritis, Knee
Procedure: radiofrequency neurotomy for genicular nerve
Procedure: radiofrequency neurotomy sham therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Therapeutic Methods for Chronic Knee Osteoarthritis Pain

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Visual analogue scale pain scores [ Time Frame: at 12 weeks after the procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oxford knee score [ Time Frame: at 12 weeks after the procedure ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: lidocaine
Local injection with lidocaine through the RF cannula without activation of RF generator.
Procedure: radiofrequency neurotomy sham therapy
The placebo (sham) group received the same procedure without activation of the RF generator.
Other Name: radiofrequency neurolysis sham therapy
Active Comparator: lidocaine, radiofrequency current
After lidocaine injection through the RF cannula, the temperature of the electrode tip was raised to 70℃ for 90 seconds by RF generator.
Procedure: radiofrequency neurotomy for genicular nerve
RF cannula was advanced percutaneously towards areas connecting the shaft to epicondyle of femur or tibia. Lidocaine (1 mL of 2%) was injected before activation of the RF generator (NeuroThermTM, Morgan automation LTD, Liss, UK). RF electrode was inserted through RF cannula. The temperature of the electrode tip was raised to 70℃ for 90 seconds by radiofrequency generator.
Other Name: neuroablation or radiofrequency neurolysis

Detailed Description:

The knee joint is innervated by articular branches of various nerves (femoral, common peroneal, saphenous, tibial and obturator) (Kennedy et al. 1982; Hirasawa et al. 2000). These articular branches around the knee joint are known as genicular nerves. Several genicular nerves can be easily approached percutaneously under fluoroscopic guidance. In our study, genicular nerves were effectively blocked with local anesthetics under fluoroscopic guidance, leading to a significant reduction in knee pain. Rf neurotomy is based on the theory that cutting the nerve supply to a painful structure may alleviate pain and restore function. we evaluate the efficacy of RF neurotomy in reducing pain and improving function in the elderly with chronic knee OA.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with chronic knee pain (i.e., knee pain of moderate intensity or greater on most or all days for ≥ 3 months)
  • patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, evaluated by a radiologist)

Exclusion Criteria:

  • acute knee pain
  • prior knee surgery
  • other connective tissue diseases affecting the knee
  • serious neurologic or psychiatric disorders
  • injection with steroids or hyaluronic acids during the previous 3 months
  • sciatic pain
  • anticoagulant medications
  • pacemakers
  • prior electroacupuncture treatments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924677

Locations
Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Chair: Pyong-hwan Park, M.D. Asan Medical Center
  More Information

Publications:
Responsible Party: Jinwoo Shin, anesthesiology and pain medicine
ClinicalTrials.gov Identifier: NCT00924677     History of Changes
Other Study ID Numbers: GN0901
Study First Received: June 18, 2009
Last Updated: June 18, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
genicular nerve
osteoarthritis
knee
neurotomy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 24, 2014